Kornimate/medical-research-clean huggingface dataset:
effect of deferasirox on patients with cardiac mri t2* < 20 msec

Conditions: Beta Thalassemia Transfusion Dependent

Summary: this study will assess the safety and efficacy of deferasirox in patients with cardiac mri t2\* \< 20 msec.


Eligibility criteria:
inclusion criteria: * β-thalassemic patients receiving regular transfusions with an history of at least 20 transfusional events * patients naïve for deferasirox * serum ferritin levels ≥1000ng/ml (average of the last 6 months assays); * cardiac mri t2\* \>5 and \<20 msec. * lvef at mri ≥56% exclusion criteria: * patients that have already started deferasirox therapy * existing contraindications to the performance of mri procedure, including presence of metallic prostheses not compatible with the mri procedure other than those approved as safe for use in mri scanners (e.g., some types of aneurysm clips, shrapnel in proximity to vital organs such as the retina), pacemaker, intractable claustrophobia and incapability to follow the instruction for the correct performance of the mri (e.g. to maintain a supine position, to hold breath, etc.) * clinical conditions requiring intensive chelating therapy on the basis of investigator's judgment * stable average alt levels \>300 u/l in the preceding 12 months * uncontrolled systemic hypertension * estimated creatinine clearance \<60 ml/min * history of nephrotic syndrome * history of clinically significant ocular toxicity related to the chelating therapy * psychiatric disorders or drug dependence that might impair the capability of the patient to provide their informed consent or to be administered the study treatment * known sensitivity to study drug(s) or class of study drug(s) * patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study * use of any other investigational agent in the last 30 days. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: thalassemia cardiac mri t2*
efficacy and safety of bortezomib as first-line treatment of acquired ttp

Conditions: Thrombotic Thrombocytopenic Purpura, Acquired

Summary: to evaluate the efficacy and safety of bortezomib in the first-line treatment of patients with acquired ttp，we design this prospective, multi-center, single-arm interventional study.all enrolled ttp patients were given bortezomib 1.3 mg/m2 intravenous injection d1, 4, 8, on the basis of standard single membrane plasma exchange (2l/d) and hormone therapy (1mg/kg prednisone or equivalent methylprednisolone). 11 (4 doses in total). bortezomib should be administered immediately after each plasma exchange, and the interval between the next plasma exchange is\> 24h. plasma exchange continued until the patient's platelet count was \>100×109/l for 2 consecutive days, and then changed to once every other day for a total of two times and then stopped.

to evaluate the efficacy and safety of bortezomib in the first-line treatment of patients with acquired ttp，we design this prospective, multi-center, single-arm interventional study.all enrolled ttp patients were given bortezomib 1.3 mg/m2 intravenous injection d1, 4, 8, on the basis of standard single membrane plasma exchange (2l/d) and hormone therapy (1mg/kg prednisone or equivalent methylprednisolone). 11 (4 doses in total). bortezomib should be administered immediately after each plasma exchange, and the interval between the next plasma exchange is\> 24h. plasma exchange continued until the patient's platelet count was \>100×109/l for 2 consecutive days, and then changed to once every other day for a total of two times and then stopped.

Eligibility criteria:
inclusion criteria: * clinically diagnosed as ttp (thrombocytopenia + maha± clinical evidence of related organ damage， a significant reduction in adamts13 activity level and/or positive antibody screening） * elder than 18 years old; * informed consent is required; exclusion criteria: * uncontrollable systemic infection; * known allergy to bortezomib; * expected survival time \<1 week; * pregnant or lactating women (women of childbearing age have a positive pregnancy test at baseline or have not received a pregnancy test. postmenopausal women must be at least 12 months after menopause); * if the creatinine level is ≥200μmol/l (1.5mg/dl), the levels of transaminase and bilirubin are 2 times higher than the upper limit of normal (except due to the primary disease); * known congenital ttp or a clear family history of ttp; * other diseases that cause microangiopathic hemolysis and thrombocytopenia, such as dic, aps, hus, malignant hypertension, transplantation-related microangiopathy; * active malignant tumors (except skin basal cell carcinoma or cervical carcinoma in situ) ( have not been treated or recurred within 5 years before signing the informed consent); * peripheral neuropathy; * patients or family members cannot understand the conditions and goals of this study; * the investigator believes that the patient should not participate in any other situations in this trial.

Keywords: thrombotic thrombocytopenic purpura bortezomib plasma exchange
mesh fixation with intraperitoneal tisseel

Conditions: Postoperative Pain; Ventral Hernia

Summary: the purpose of this study is to determine whether mesh fixation in laparoscopic umbilical hernia repair with fibrin glue is superior to tacks in terms of postoperative pain and recovery.


Eligibility criteria:
inclusion criteria: * age: 18-85 years and danish speaking * umbilical hernia ø 1.5 - 5 cm at preoperative clinical examination * asa group i-iii exclusion criteria: * former laparoscopic umbilical herniotomy * incarceration * drug/alcohol abuse/ongoing use of strong analgesic * bad compliance * liver disease child-pugh stage b/c * immunodeficiency (ex. steroid use) * pregnancy * other hernias recognized perop. and operated on at the same operation * lack of consent

Keywords: surgical fixation devices postoperative pain ventral hernia fibrin tissue adhesive laparoscopy quality of life fatigue
a study of objective fitting for focused multipolar stimulation

Conditions: Hearing Loss, Bilateral

Summary: the purpose of this exploratory study is to trial various objective and behavioural fitting methods for potential use with focused multipolar stimulation programming.

this study will compare various objective and behavioural fitting methods for the programming of focused multipolar stimulation. fitting methods will be assessed for both performance and clinician-rated experience to determine the most practical and beneficial method to balance ease of fitting and performance. focused multipolar stimulation (fms) is an alternative to the standard of care monopolar stimulation (mp). fms may improve spectral resolution through reduced cochlear spread of excitation and in turn provide enhanced speech perception and real-world clinical improvement over mp stimulation.

Eligibility criteria:
inclusion criteria: 1. moderately severe to profound sensorineural hearing loss in both ears. (i.e., \>55 db hl pure-tone average loss) 2. candidate for unilateral cochlear implantation according to locally approved criteria. 3. aged 18 years or over. 4. fluent speaker in the language used to assess speech perception performance. 5. willing and able to provide written informed consent. exclusion criteria: 1. unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator. 2. investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 3. cochlear employees or employees of contract research organisations or contractors engaged by cochlear for the purposes of this investigation. 4. pregnant at the time of surgery. 5. prisoners, or anyone in custody. 6. current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device. 7. previous or existing cochlear-implant recipient. 8. evidence of severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age. 9. duration of severe to profound hearing loss \>20 years in the ear to be implanted. 10. ossification or other cochlear anomaly that might prevent complete insertion of the electrode array. 11. diagnosis of auditory neuropathy. 12. deafness due to lesions of the acoustic nerve or central auditory pathway. 13. additional handicaps that would prevent or restrict participation in the audiological evaluations. 14. unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device.
this is a retrospective observational study looking at the characteristics and outcomes of participants taking inflectra using the corevitas rheumatoid arthritis registry

Conditions: Arthritis, Rheumatoid

Summary: this is a retrospective observational study looking at the characteristics and outcomes of participants taking inflectra using the corevitas rheumatoid arthritis registry.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age * have been diagnosed with ra by a rheumatologist * have initiated treatment with inflectra * had assessment of effectiveness in patients who have at least one follow up visit. exclusion criteria: * no additional exclusion criteria
a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of the sufentanil nanotab pca system/15 mcg (zalviso™) for the treatment of post-operative pain in patients after open abdominal surgery

Conditions: Post-Operative Pain

Summary: the purpose of this study is to compare the efficacy and safety of the sufentanil nanotab pca system/15 mcg to the placebo sufentanil nanotab pca system for the management of acute moderate to severe post-operative pain after open abdominal surgery.


Eligibility criteria:
inclusion criteria: * male or female patients who are 18 years or older * patients who are scheduled to undergo an open abdominal surgery (including laparoscopic-assisted) under general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation. * post-surgical patients who have been admitted to the pacu and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery. exclusion criteria: * patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of vicodin®, norco®, lortab® with 5 mg hydrocodone per tablet). * patients with an allergy or hypersensitivity to opioids. * female patients who are pregnant or breast-feeding

Keywords: in patient, post operative pain adult post-operative inpatients who are expected to require parenteral opioid analgesia for at least 48 hours after open abdominal surgery
quality of life and function of patients with pelvic tumors after undergoing hemipelvectomy

Conditions: Malignant Primary Pelvic Neoplasm

Summary: this study aims to determine the functional outcomes of patients who underwent internal hemipelvectomy with or without reconstruction or external hemipelvectomy for pelvic tumors. learning about the outcomes of these patients may help researchers determine the long-term effects of different types of hemipelvectomy procedures and may help improve quality of life.

primary objective: i. to determine functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy. secondary objectives: i. to determine factors that influence the functional outcomes of these patients following surgery. ii. assess sexual and urinary function in patients who have undergone internal or external hemipelvectomy. iii. determine whether type of surgery influences long-term sexual and urinary function. outline: patients undergo physical performance assessments and complete quality of life assessments and questionnaires pre-hemipelvectomy, at 6 weeks post-hemipelvectomy, and then every 3 months up to 12 months and yearly thereafter for 10 years. patients who are 1 year out from surgery complete pain-related questionnaires once. patients who have already undergone hemipelvectomy prior to enrollment undergo medical record review.

Eligibility criteria:
inclusion criteria: * patients within the institution who have undergone or will undergo a hemipelvectomy exclusion criteria: - none
epidemiology of injuries in elite badminton players: a prospective study

Conditions: Sport Injury

Summary: objective: to determine the incidence and characteristics of injuries in elite badminton players over a competitive season. design: 12-months prospective cohort study setting: the french national institute of sport, expertise, and performance (insep). participants: twenty international elite badminton players independent variables: the type, the location, the occurrence of the injury (match or training), the footwork type, the type of shot and the perceived fatigue were collected. main outcome measures: injury incidence rates were calculated per 1000 hours of play (hop).


Eligibility criteria:
inclusion criteria: * badminton players training at the at the french national institute of sport, expertise, and performance (insep) * participant competing at an international level * medical follow-up over the 12-months duration of the study exclusion criteria: * participant unable to speak and read french language * participant under the age of 18 * lack of informed and signed consent

Keywords: epidemiology, incidence, athletic injuries, racquet sports, badminton
azopt (brinzolamide 1.0%) plus travatan (travoprost 0.004%) in treating patients with chronic angle-closure glaucoma (cacg)

Conditions: Intraocular Pressure

Summary: to evaluate the iop (intraocular pressure) lowering efficacy and safety of brinzolamide 1.0% (azopt), dosed twice daily as adjunctive therapy in patients treated with travoprost 0.004% (travatan) once daily. the study is double masked. the patients will receive either treatment for 12 weeks.


Eligibility criteria:
inclusion criteria: * ≥ 18 years; * cacg (chronic angle closure glaucoma) ≥ 1eye * have been treated with pga (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and iop=19-32 mmhg (millimeters mercury) in at least one eye and ≤ 32 mmhg in both eyes * clinical stability of va (visual acuity) and optic nerve throughout the study exclusion criteria: * abnormality restricts exam of the fundus or anderior chamber * conjunctivitis, keratitis or uveitis * unable to be discontinued from using all ocular hypotensive medication(s) except travatan (travoprost 0.004%) and/or azopt (brinzolamide 1.0%) for 12days-4weeks * ocular surgery prior to the study

Keywords: iop lowering efficacy and safety of azopt plus travatan
artisan aphakia lens for the correction of aphakia in children

Conditions: Aphakia

Summary: the purpose of this study is to determine the safety and effectiveness of the artisan aphakia lens in the treatment of aphakia in children.


Eligibility criteria:
inclusion criteria: * 2 to 21 years of age * have a visually significant cataract or need iol replacement surgery * compromised capsular bag prohibiting implantation of standard posterior iol * subject or parent/guardian must be able to comply with visit schedule and study requirements * subject's legal representative must be able to sign the informed consent exclusion criteria: * under 2 years of age * unable to meet postoperative evaluation requirements * no useful vision or vision potential in fellow eye * mentally retarded patients * history of corneal disease * abnormality of the iris or ocular structure * acd less than 3.2 mm * uncontrolled glaucoma * iop \> 25 mmhg * chronic or recurrent uveitis * preexisting macular pathology that may complicate the ability to assess the benefit of this lens * retinal detachment or family history * retinal disease that may limit visual potential * optic nerve disease that may limit visual potential * diabetes mellitus * pregnant, lactating or plan to become pregnant

Keywords: aphakia secondary intraocular lens congenital cataract marfan syndrome pediatric cataract ectopia lentis subluxated lens
a prospective cohort of patients with cervical/intracranial arteries stenosis in china

Conditions: Cervical Artery Stenosis; Intracranial Artery Stenosis

Summary: the aim of this study is to establish a prospective cohort of patients with cervical/intracranial arteries stenosis in china.

a prospective cohort of patients with cervical/intracranial arteries stenosis from various regions of china will be established. this prospective cohort is used to identify the distribution of risk factors in the patients with cervical/intracranial arteries stenosis.

Eligibility criteria:
inclusion criteria: 1. age ≥ 40 and ≤ 80 years; 2. ultrasound or imaging examinations indicating cervical artery stenosis and/or intracranial artery stenosis (including mild, moderate, severe stenosis, or occlusion); 3. willing to participate and signing the informed consent form. exclusion criteria: 1. patients with stroke occurring within the past year; 2. patients with severe systemic diseases, such as respiratory failure, renal failure, gastrointestinal bleeding, coagulation disorders, malignancies, etc.; 3. patients with a life expectancy of less than one year or those who are unable to complete the study for other reasons.

Keywords: cervical artery stenosis intracranial artery stenosis
natural history of apparent mineralocorticoid excess syndrome

Conditions: Apparent Mineralocorticoid Excess Syndrome

Summary: apparent mineralocorticoid excess (ame) is a rare inherited disease that can cause severe high blood pressure and low blood potassium in children and adults. it is caused by abnormal hormone metabolism and can be fatal. this study will focus on the genetic basis, natural history, disease progression, and survival of people with ame.

ame is a rare genetic disorder that is caused by a mutated hsd11b2 gene, which encodes the metabolic enzyme 11bhsd2. the altered gene interferes with the ability of 11bhsd2 to inactivate the hormone cortisol. above-normal cortisol activity then leads to a rise in blood pressure and a reduction of potassium in the blood. it also leads to low levels of the enzyme renin and the hormone aldosterone, both of which are involved in the regulation of long-term blood pressure. long-term high blood pressure and metabolic defects start at an early age in children with severe ame. in others, ame may start later in life and cause less serious side effects. symptoms can include poor growth in childhood, delayed puberty, muscle weakness, heart rate irregularity, frequent urination, and thirst. if left untreated, ame can cause serious damage to the eyes, kidneys, heart, and other organs. current treatment with the synthetic steroid spironolactone usually improves symptoms; however, despite treatment, some individuals with ame still experience disease progression and even death within years of being diagnosed with ame. understanding more about ame, how it progresses, and how it affects people differently may help to improve treatment options. the purpose of this study is to examine the genetic basis, natural history, disease progression, and outcome of children and adults with ame. the study will also examine the family members of study participants with ame for any genetic abnormalities and possible mild forms of ame. this study will last 2 to 7 years. participants and their family members will attend yearly study visits that will include interviews about medical history, symptoms, and hospital stays; a physical exam; blood pressure testing; and blood and urine collection. interim reviews of medical records will occur as necessary. children will undergo an x-ray of the left hand. during the initial study visit, participants will be asked questions about family members and birth size.

Eligibility criteria:
inclusion criteria for participants with ame: * high blood pressure characterized by low plasma renin and serum aldosterone levels * elevated urinary cortisol/cortisone metabolite ratio (\[thf + 5athf\]/the) * molecular genetic diagnosis of ame with two mutations of the hsd11b2 gene inclusion criteria for family members without genetic diagnosis of ame: * carrier of the hsd11b2 mutation that the ame participant has exclusion criteria for all participants: * any other illness or condition that might interfere with study participation

Keywords: hypertension metabolic alkalosis hypokalemia
the effect of administration on n-acetylcysteine on serum creatinine levels in patients with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: primary outcome: serum creatinine change at 4 hours and 48 hours following 4 doses of n-acetylcysteine (total 4800 mg) compared to baseline serum creatinine. secondary outcome: serum cystatin c change at 4 hours and 48 hours post 4 doses of n-acetylcysteine compared to baseline serum cystatin c.

n-acetylcysteine has been reported to lower serum creatinine in normal individuals. the mechanism of this effect is unknown but possible stimulation of tubular secretion of creatinine has been hypothesized based upon a lack of effect on cystatin c levels. if this effect also occurs in subjects with chronic kidney disease, interpretation of clinical trials using n-acetylcysteine for prophylaxis of acute kidney injury would be confounded. to answer whether such confounding occurs, 50 patients with stable chronic kidney disease (stage 3-5) will be given 4 doses of n-acetylcysteine, 1200 mg each, with measurement of serum creatinine and cystatin c before, 4 hours and 48 hours after the last dose. no other interventions, including changes in medications, will be permitted during the study.

Eligibility criteria:
inclusion criteria: * estimated gfr 10-59 ml/min/1.73m2 by 4 variable mdrd equation * less than a 10% difference between the baseline creatinine and the recruitment creatinine obtained within 3 months of the trial exclusion criteria: * unable to give informed consent * unwillingness to return for follow-up blood sampling * unstable renal function * subjects taking h2-blockers